Shuren Takes the Helm at CDRH, Issues Agenda for 2010.  Dr. Jeffrey Shuren has been named the permanent director of FDA’s device center, after serving as acting director since September 2009.  Shuren, a neurologist and attorney, has been a long time member of the FDA staff and was involved with key agency initiatives in recent years.  In tandem with taking the permanent post, Shuren released an aggressive agenda for the device center in 2010.  Priorities in the agenda include implementing changes to the 510(k) program by the fall, improving the quality of clinical data used to support premarket approval applications via guidance and other measures, implementing a unique device identifier system by 2013, and harmonizing regulatory inspections and activities overseas.  

FDA Issues Guidance on Heart Valve Clinical Studies.  Five years after withdrawing guidance deemed no longer timely, FDA has issued new draft guidance regarding the requirements for clinical studies of heart valve replacements.  Though the guidance primarily addresses trials of valves placed during open-heart surgery, the agency says the guidance also applies to percutaneous valve replacements, though industry expects the data requirements will be greater for studies of the percutaneous devices.  The draft proposes that firms conducting studies of the valves enroll 150-300 subjects at eight or more sites and follow these subjects for at least one year. 

Device Firms Struggling with Corrective and Preventive Actions.  Some device companies have been inaccurately implementing corrections, corrective actions, and preventive actions, out of a misunderstanding as to the role of each activity.  According to FDA, firms often respond to agency inspections by noting the actions they have taken, failing to realize that they are not using the appropriate methods to address an identified problem.  Corrections, which are individual “fixes” to address a particular problem or product, are different from corrective actions, which are systemic changes taken to prevent an identified problem from recurring.  Importantly, many firms confuse corrective actions with preventive actions, which are implemented prior to identification of a problem and thus cannot be corrective in nature.  

Radiological Devices Review Moves to OIVD.  The Radiological Devices Branch of FDA is being moved to the Office of In Vitro Diagnostic Device Evaluation and Safety (“OIVD”), according to the agency.  Thus, OIVD will now oversee the large staff of the Radiological Devices Branch and, ultimately, the review of premarket submissions for radiological devices, such as medical imaging devices and cancer radiation therapies.  Previously, the Radiological Devices Branch was a part of the Office of Device Evaluation and OIVD was responsible largely for in vitro diagnostic devices. 

NIH Spent $40 Million on Comparative Studies of Devices.  The National Institutes of Health (“NIH”), which was tasked with conducting $400 million worth of comparative effectiveness research in 2009 and 2010, spent $40 million in 2009 on studies comparing medical devices. The majority of these studies involved medical imaging devices, with significant funds also allocated to the study of in vitro diagnostics.  Many studies involved direct, head-to-head comparisons, not solely of clinical performance, but also of cost-effectiveness.  NIH plans to spend as much as $200 million in 2010 on comparative effectiveness studies.

Industry Pushing FDA for Companion Diagnostics Guidance.  A broad spectrum of industry groups and coalitions are urging FDA to issue guidance for companies developing companion diagnostics in conjunction with disease treatments.  Though the agency issued a concept paper in 2005, FDA has not yet followed-up on this paper with a specific guidance document.  According to FDA, an internal working group is now drafting such guidance, which the agency hopes will address a broad range of issues faced by firms attempting to develop companion diagnostics.  In tandem, trade groups and coalitions are developing recommendations to advise FDA on the guidance. 

Contrast Imaging Guidance Published, Concerns Remain.  On January 5, 2010, FDA published final guidance regarding the use of medical imaging devices and approved contrast agents.  The guidance attempted to clarify what types of marketing applications companies should submit when seeking to market these devices for use with the approved drugs.  Similarly, the guidance sought to aid companies in determining when changes to the labeling for an imaging device merit changes to the contrast agent labeling.  The final guidance does not address all industry critiques of the earlier draft guidance, however.  For example, the guidance does not specify data requirements for specific indications, as requested by industry. 

Weekly Device Summaries for Jan. 4 - 8, 2010

FDA Inspections to Increase, Tougher Responses Expected.  FDA officials are warning device firms to remain vigilant in maintaining quality systems and to be prepared for an inspection at any time, as FDA leadership delivers on its promise to enhance enforcement by the agency.  FDA plans to continue increasing the number of device facility inspections in 2010, following an upswing in inspections during 2009.  The agency is also warning device firms that FDA will follow-up more quickly than in previous years, if any violations are found during an inspection. 

Industry Still Focused on Device Tax as Negotiations Continue.  As Congress attempts to create one health reform bill from the two passed by the House and Senate, the device industry continues to concentrate its efforts on the device tax provisions of the bills.  The final bill likely will include a $20 billion tax on the device industry, to be paid over a series of years.  However, certain details differ in the two versions of the bill, and device firms are hoping the more favorable provisions are selected for the final health reform package.  Provisions relating to the date the device tax would take effect, whether payments made toward the tax would be tax-deductible, and exemptions for small device firms are still being debated. 

Coalition Urges Use of Technology to Curb Imaging.  Last year, a report from the Government Accountability Office caused a stir when it urged the federal government to use radiology benefits managers (“RBMs”) to curb overutilization of medical imaging, in order to lower costs to the Medicare program.  In response to the report, a coalition of organizations, including the American College of Radiology, is now lobbying the government and private insurers to use software-based support tools that incorporate treatment guidelines, to keep physicians from overuse of imaging.  The tools steer physicians toward imaging choices supported by medical evidence, and the coalition says this allows imaging decisions to remain in clinicians hands, rather than the hands of RBMs.  

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